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Therapy and Prophylaxis for Genital Tract Infection

Award Number: R44AI104067
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2013
PERIOD OF PERFORMANCE END DATE: 04/30/2023

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Therapy and Prophylaxis for Genital Tract Infection - PROJECT SUMMARY/ABSTRACT Genital tract infection with Neisseria gonorrhoeae does not induce a state of specific protective immunity and can be acquired repeatedly. Despite public health measures, the disease persists at an unacceptably high frequency; there is no vaccine against it, and resistance even to the latest generations of antibiotics continues to emerge. TherapyX, Inc. is advancing GneX12, a novel immune therapeutic that is designed to enhance antibiotic-mediated clearance of persistent Neisseria gonorrhoeae infection and induce long-term protection against subsequent exposure, i.e. a therapeutic vaccine. Specifically, GneX12 is the canonical type 1 cytokine interleukin-12 (IL-12) encapsulated in proprietary biodegradable sustained-release microparticles. Phase I studies in a murine model of gonoccal infection demonstrated that intra-vaginal administration of GneX12 achieved rapid disease clearance and induced the development of long-term protective immunity. Phase II work optimized treatment schedule; demonstrated the critical role of Th1 immunity in disease clearance; revealed that long-term protection was mediated by an anti-gonoccocal humoral response; that the antibodies were cross- protective; and that co-administration with antibiotics did not interfere with the induction of long-term protection. Additional Phase II work established scale-up manufacturing processes and completed a type C meeting with the FDA, garnering agency agreement with our single species primate toxicology plan to support an investigative new drug application (IND). The aims of the current Phase IIb application are based on agency recommendations communicated during that meeting. Specifically, Aim 1 studies will complete additional toxicology, including reproductive toxicology, assessment in rodents as recommend by FDA. In Aim 2, a large-batch “GMP-like” GneX12 drug product is manufactured in compliance with FDA drug substance and drug product release recommendations for use in IND-enabling, non-human primate toxicology studies. A meeting request and package, including final CMC and pre-clinical toxicology questions and finalized clinical protocols, will then be prepared and submitted for a Type B meeting with the FDA (Aim 3). Lastly, based on the FDA guidance obtained in Aim 3, initial tolerability and pK of GneX12 in non-human primates is established and IND readiness is assessed (Aim 4) in preparation for an open IND and first-in-man clinical trials. The long-term goal of this project is to develop a biologic, which when administered in conjunction with antibiotics, will not only enhance disease clearance but will also induce long-term protective immunity. No similar product currently exists.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	THERAPYX, INC.	701 ELLICOTT ST	BUFFALO	NY	14203	ERIE	USA	Allergy and Infectious Diseases Research	000	6	2/16/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $915,331 )
2022	2022	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	6	4/25/2022	NON-COMPETING CONTINUATION	$915,331
														Subtotal = $915,331

Issue Date FY: 2021 ( Subtotal = $1,000,000 )
2021	2021	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	5	4/23/2021	NON-COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $1,000,000 )
2020	2020	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	4	5/1/2020	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,000,000

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2015	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	3	6/5/2017	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $749,000 )
2015	2015	THERAPYX INC	138 FARBER HALL 3435 MAIN ST	BUFFALO	NY	14214	ERIE	USA	Allergy and Infectious Diseases Research	000	3	4/27/2015	NON-COMPETING CONTINUATION	$749,000
														Subtotal = $749,000

Issue Date FY: 2014 ( Subtotal = $749,000 )
2014	2014	THERAPYX INC	138 FARBER HALL 3435 MAIN ST	BUFFALO	NY	14214	ERIE	USA	Allergy and Infectious Diseases Research	000	2	6/6/2014	COMPETING CONTINUATION	$749,000
2014	2014	THERAPYX INC	138 FARBER HALL 3435 MAIN ST	BUFFALO	NY	14214	ERIE	USA	Allergy and Infectious Diseases Research	001	2	7/18/2014	COMPETING CONTINUATION	$0
														Subtotal = $749,000

Grand Total All Awards = $4,413,331

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Therapy and Prophylaxis for Genital Tract Infection

Award Number: R44AI104067

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2013

PERIOD OF PERFORMANCE END DATE: 04/30/2023

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